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Displaying 1 - 15 of 30 items.
EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance to specific SARS-CoV-2 Subvariants
UPDATED INFORMATION – 2023/01/17
Neutralization data for the following SARS-CoV-2 Omicron subvariants have been added to the Canadian Product Monograph: Omicron BA.2.75.2, BF.7, BJ.1, BN.1, BQ.1, BQ.1.1, and XBB. See Table 1 (below) for a summary…
AlertHealth professional risk communication | 2023-01-17
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
On December 9, 2022, Health Canada authorized a new formulation of the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory…
AlertHealth professional risk communication | 2022-12-09
SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Health Canada authorized SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) on November 3, 2022. In order to provide rapid access to the vaccine, Moderna will distribute product vials and cartons labelled in English only with the…
AlertHealth professional risk communication | 2022-11-18
EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance
EVUSHELD (tixagevimab and cilgavimab for injection) may not be effective against certain SARS-CoV-2 Omicron subvariants.
Audience
Healthcare professionals including physicians, pharmacists, nursing staff and public health officials.…
AlertHealth professional risk communication | 2022-10-26
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
On October 7, 2022, Health Canada authorized the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2…
AlertHealth professional risk communication | 2022-10-07
Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Health Canada authorized SPIKEVAX Bivalent (elasomeran/imelasomeran) on September 01, 2022. In order to provide rapid access to SPIKEVAX Bivalent, Moderna will distribute product vials and cartons labelled in English only with the brand name “SPIKEVAX 0…
AlertHealth professional risk communication | 2022-09-02
Distribution of a New Presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) with English-only Vial and Carton Labels
A new presentation of SPIKEVAX (elasomeran) with a concentration of 0.10 mg/mL in a 2.5 mL multidose vial was authorized on June 01, 2022. In order to provide rapid access to the new presentation of SPIKEVAX (0.10 mg/mL, 2.5 mL multidose vial), Moderna…
AlertHealth professional risk communication | 2022-06-06
Distribution of EVUSHELD (tixagevimab and cilgavimab for injection) with English-Only Vial and Carton Labels
EVUSHELD (tixagevimab and cilgavimab for injection) was authorized by Health Canada on April 14, 2022. In order to provide rapid access to EVUSHELD in the context of the global COVID-19 pandemic, AstraZeneca will distribute product vials and cartons with…
AlertHealth professional risk communication | 2022-04-14
Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2 Omicron BA.2 Subvariant
Sotrovimab, 500 mg IV, is unlikely to maintain efficacy against the Omicron BA.2 subvariant. Sotrovimab demonstrates reduced in vitro neutralization against the Omicron BA.2 subvariant.
Audience
Healthcare professionals responsible…
AlertHealth professional risk communication | 2022-04-14
Distribution of NUVAXOVID with English-only Vial and Carton Labels
NUVAXOVID was authorized by Health Canada on February 17, 2022. In order to provide earlier access to NUVAXOVID in the context of the global pandemic, Novavax, Inc. will distribute product vials, cartons and package inserts that are in English only for a…
AlertHealth professional risk communication | 2022-02-23
PAXLOVID (nirmatrelvir and ritonavir) - Dosing and Dispensing in Renal Impairment, Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only Labels
UPDATED INFORMATION - July 6, 2022
A new PAXLOVID dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN: 02527804. Pfizer has introduced this new packaging configuration to…
AlertHealth professional risk communication | 2022-01-17
Casirivimab and Imdevimab – High Risk of Treatment Failure Due to Circulation of SARS-CoV-2 Omicron Variant
There is a high risk of treatment failure with the casirivimab and imdevimab combination based on analysis of neutralization activity against selected mutations of the SARS-CoV-2 Omicron variant. The Canadian Product Monograph for casirivimab and…
AlertHealth professional risk communication | 2022-01-07
Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic
Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic
Starting date:
September 22, 2021…
AlertHealth professional risk communication | 2021-10-04
AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Capillary Leak Syndrome
AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Capillary Leak Syndrome
Starting date:
June 29, 2021…
AlertHealth professional risk communication | 2021-06-29
Importation of COVID-19 Vaccine Moderna with up to 15 Doses per Vial and English-only Vial and Carton Labels (US-Labelled Supply)
UPDATED INFORMATION – October 29, 2021
Further to the Health Canada communications below issued on June 14, 2021 (and updated on June 24, 2021, and August 3, 2021), Health Canada has authorized a 2-month shelf life extension (from 7 months to 9 months…
AlertHealth professional risk communication | 2021-06-14